DILTIAZEM HYDROCHLORIDE
- Product NDC
- 53002-1521
- 11-digit product format
- 530021521
- Labeler code
- 53002
- Product ID
- 53002-1521_95753a49-5cbd-40c0-87a4-5a80aefab934
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DILTIAZEM HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA074943
- Marketing category
- ANDA
- Marketing start
- 2001-07-30
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1521-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-bc8f-f424-e053-dadaa90a57ce | DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage), 120 mg, 180 mg and 240 mg |
| 53002-1521-0 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-bc8f-f424-e053-dadaa90a57ce | DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage), 120 mg, 180 mg and 240 mg |
| 53002-1521-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-bc8f-f424-e053-dadaa90a57ce | DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage), 120 mg, 180 mg and 240 mg |
| 53002-1521-0 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-bc8f-f424-e053-dadaa90a57ce | DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage), 120 mg, 180 mg and 240 mg |
| 53002-1521-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bc8f-f424-e053-dadaa90a57ce | DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage), 120 mg, 180 mg and 240 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1521-0 | DILTIAZEM HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1521 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_b7e0adf6-f1ab-432f-a632-0fbbfc519792.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1521-0 | 53002152100 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1521-0) | 2018-10-01 | 0000-00-00 | No | No | Current |